Form
Powder
Appearance
Yellow powder
Source
Synthetic
Impurity Profile
Related Substances (HPLC):
RRT - 0.63: Not more than 0.5%
RRT - 0.89: Not more than 0.3%
RRT - 1.8: Not more than 0.5%
Related Compound A: Not more than 1.0%
Any other impurity: Not more than 0.2%
Total other impurities: Not more than 1.0%
Total impurities: Not more than 1.5%
Water Content (Karl Fisher)
Not more than 1.0%
Assay
(HPLC): 97.5% - 101.5%
Residue On Ignition
Not more than 0.1%
Heavy Metals
Not more than 10ppm
Residual Solvents
Methanol: Not more than 2000ppm
Chloroform: Not more than 60ppm
Dichloromethane: Not more than 600ppm
Acetonitrile: Not more than 410ppm
